Blog Archives


Assay Automation Ability - Lyophilized reagents for in vitro whole blood assays

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The need to implement robust biomarkers in clinical trials has never been greater, and such efforts can be easily compromised by reagent instability or simple human error during assay set-up. Many biotechnology and pharmaceutical companies are introducing efforts to conduct biomarker studies under more rigorous settings, and the use of plates or tubes pre-loaded with stimulation or staining reagents could be of value for studies that involve flow cytometry.
The value of this approach is that it lends itself to assay automation easily and safeguards against omission or erroneous addition of bulk liquid formulations of PMA and ionomycin to the reaction vessel (i.e., plate or tube) and also lends itself to extended stability/shelf-life of these reagents. On the basis of this initial success, we plan to expand our evaluation of lyophilized reagents so that they can be incorporated into our clinical biomarker campaigns as appropriate.

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ImmunoSite Technologies Allies with Goodwin Biotechnology Increasing Capabilities


Working together, ImmunoSite Technologies and Goodwin Biotechnology companies offer enhanced abilities to develop, test and manufacture biopharmaceuticals

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ImmunoSite Technologies Allies with Immudex for More Effective T Cell Response Monitoring

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Working together, companies offer enhanced abilities to monitor immunotherapy response in vaccine and drug studies.

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Research Poster - Assay Standardization Saves Money

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The identification and application of correlates of immune response can enable significant time and money savings especially in clinical trial settings for vaccine and biologic R&D. To download, please fill in the form below: [email-download download_id="2" contact_form_id="3"]

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The Need for New Surrogate Markers for Immune Monitoring and Efficacy Assessment

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Current Paradigm Needs Change

It is of concern of all in pharma and biotech research fields that the number of vaccines and drugs that get to the market is very low compared to the number that enter phase I clinical trial testing. For this to change, among other improvements, new surrogate markers must be identified early on for the purpose of patient stratification, immune monitoring and/or therapeutic or prophylactic efficacy assessment.

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How Useful are Cell Mediated Immunity Assays in Assessing Immune Response or Immunogenicity?

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If, Then

How practical is it to run validated and standardized cellular assays to interrogate biomarker surrogate correlates of immunity in clinical trial settings? Can this be done with any level of confidence in the outcome? Can these assays be performed routinely?

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What Do You Seek In A Contract Research Partnership?   In a time of tight budgets and careful examination of the cost/benefit of partnering with a contract research service provider, ImmunoSite Technologies, LLC (IST) offers a rare combination of experience, knowledge, responsiveness, and trustworthiness.  IST knows what clients need to be successful, and how to […]

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Special Phacilitate Session on Cell Mediated Immunity

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Dr. Wade E. Bolton, president & CEO of ImmunoSite Technologies, moderated a special session on Cell Mediated Immunity (CMI) at the Phacilitate Vaccine Forum in Washington, DC, on Tuesday, January 25, 2011. Topics included: Do you want standardized assays to interrogate surrogate correlates of immunity? Do you need high-throughput, validated, and automated assays to measure immunogenicity? […]

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Validation of Cell-Based Assays in the GLP Setting

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Readers gain an understanding of the details and the high level considerations of assay qualification for difficult cell-based assays. The level of optimization described for cell-based assays lends itself to biomarker assay automation which can be used for biomarker qualification and validation studies to the satisfaction of the FDA, EMEA, and other regulatory agencies.
Cell-based assay platforms covered are flow cytometry, intracellular cytokine ICS, immunophenotyping, elispot, IHC, cylex, neutralization bioassays, and endpoint assays.

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